This site uses optional cookies which are currently not set, but will be if you visit another page. Find out more about the cookies we use.

Need any help? Call us on
01270 258530

New Rules on REACH Data Sharing

16 November 2015

The Commission Implementing Regulation (EU) on joint submission of data and data-sharing in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was voted unanimously by the REACH Committee on the 22ndOctober 2015.

The new rules will not be subject to the usual three-month scrutiny period and will be implemented twenty days after the European Commission publish the regulation in the Official Journal.  However, the European Chemicals Agency will need to amend and publish revised guidance in line with the new provisions.

REACH requires manufactures and importers to collect data on their substances and use it to prepare registration dossier and to assess the risks related to this substance and to develop appropriate risk management measures. Whenever necessary data are missing, Substance Information Exchange Forums (SIEF) participants are required to inquire whether a relevant study is available within the SIEF. This is mandatory for studies involving tests on vertebrate animals and it is possible for other data.

The basic principle endorsed by the Commission is that cost sharing should be ‘determined in a fair, transparent and non-discriminatory manner.’  Agreements to share data should be ‘structured in a way that all relevant costs are clearly described and identifiable’.

The new Implementing Regulation aims to facilitate the data sharing process as follows:

·         Clarify the specific duties and obligations for parties to agreements where the sharing of information and associated costs is required under Regulation (EC) No 1907/2006

·         Improve transparency within SIEF

·         Ensure the costs are shared in a fair, transparent and non-discriminatory way – all costs must be itemised and justified

·         Provide assistance for dispute resolution

New members joining a SIEF after the new rules come into force are not bound by any agreement between the existing members and can require the SIEF to comply with the provisions of the new rules.

If you have any questions relating to data-sharing, contact ReFaC now.

Cookies required

To use this functionality please enable cookies. Find out more about our cookie policy.

  Cookies are currently off.